A Calcitriol capsule contains 0.25 micrograms of active — a quantity you could not see on the tip of a needle. Getting exactly that amount into every one of a million capsules is not something a tablet press does comfortably. A softgel does it every day. That is the quiet reason so many pharmaceutical products are made as soft gelatin capsules.
- Softgels dose liquids precisely, which suits micro-dose actives such as Calcitriol.
- Oil-soluble drugs such as Isotretinoin and Dutasteride can be delivered pre-dissolved in a lipid fill.
- The sealed shell limits oxygen exposure and masks taste and odour.
- Choose a pharmaceutical softgel manufacturer with a drug licence, WHO-GMP certification and batch documentation.
Why pharmaceutical companies choose softgels
Softgels are made by injecting a liquid fill into a sealed gelatin (or vegetarian) shell. For pharmaceutical products that brings four practical advantages:
- Content uniformity for low doses. Metering a liquid is more precise than blending a few micrograms of powder into a tablet mass.
- Oil-soluble and poorly water-soluble actives. The active can be presented already dissolved or finely suspended in a lipid vehicle.
- Protection. The hermetically sealed shell limits oxygen exposure for sensitive ingredients.
- Patient acceptance. Smooth, odourless capsules that are easy to swallow.
Pharmaceutical softgels in practice
| Therapeutic area | Examples manufactured as softgels |
|---|---|
| Bone health | Calcitriol 0.25 mcg and 0.5 mcg; Calcitriol with Calcium, Zinc, Magnesium or Vitamin K2-7 |
| Dermatology | Isotretinoin 5 mg, 20 mg, 30 mg and 40 mg |
| Men’s health | Dutasteride; Sildenafil Citrate soft gelatin capsules |
| Women’s health | Clotrimazole & Clindamycin and Fenticonazole vaginal softgels |
| Neuro & pain | Pregabalin with Mecobalamin; Pregabalin 300 mg |
You can see the full list of formulations on our softgel capsules range.
What changes in development
Moving a drug into a softgel is not just a change of container. The fill has to be compatible with the shell — high water content, for example, can soften gelatin — and the active has to stay stable in the fill over shelf life. A capable manufacturer will review compatibility, run trial batches and support stability work before commercial production.
Choosing a pharmaceutical softgel manufacturer
- Drug manufacturing licence covering the product category.
- WHO-GMP certified facility.
- Documented in-process controls and a certificate of analysis for every batch.
- Batch manufacturing records that support your registrations.
- Experience with the specific therapeutic category you are launching.
Read how we work as a pharmaceutical softgel manufacturer for pharma companies, PCD partners and export customers.
